Featured Articles
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Drug Repurposing Advantages And Strategies
Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.
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Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication
7/22/2020
Cure HHT, a foundation representing patients suffering from Hereditary Hemorrhagic Telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an Investigational New Drug (IND) application with the FDA.
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Oxygen Sensitive Drug Products
Primary packaging is thought of as the first line of defense against the negative effects of oxygen. This article highlights other areas to consider that can help avoid drug quality degradation.
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Understanding Emergency Use Authorization (EUA)
Emergency Use Authorization (EUA) is a term that became part of the COVID-19 daily news briefings. What exactly is EUA? When is it used? How do the public health community, FDA, and drug developers authorize emergency use of drugs or other medical products?
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Accelerate The Start Of Your Outsourced Pharmaceutical Project
In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).
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Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity Controlled Pharma Company
The role of Chief Financial Officer for a small-to-mid size pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.
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Meet Barbara Holland, Business Development Director
5/12/2022
Barbara Holland, Business Development Director at Pii, is a bit of a renaissance woman. Learn about her personal interests and why she came out of retirement to work with customers.
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CDMO Innovation For The Future Pharmaceutical Supply Chain
We have a longstanding mantra, “challenges frame opportunities.” This applies to how we intentionally innovate, modernize, and introduce new capabilities and expand capacity.
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Snapshot Of The Parenteral Drug Delivery Market
6/17/2022
Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
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Demystifying Highly Potent API And Cytotoxic Drug Products
The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.